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This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CWP232291 | Experimental | Phase 1a: single administration of CWP232291 , Phase 1b: CWP232291 combination with Lenalidomide and Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1a: CWP232291 | Drug | CWP232291 administered alone twice weekly every 4 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended dose of Phase 2 trial of CWP232291 | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax as a pharmacokinetic parameter of 'CWP232291' | Peak plasma concentration(Cmax) of 'CWP232291' | Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion |
| AUC as a pharmacokinetic parameter of 'CWP232291' |
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Inclusion Criteria:
Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment.
≥ 18 years of age.
Confirmed measurable MM based on the following:
Failed 2 or more prior standard MM therapies, and >100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ≥ 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
Eastern Cooperative Oncology Group (ECOG) performance score 0-2 (Appendix 3).
Adequate bone marrow function:
Adequate renal function:
Adequate hepatic function:
11. Women of child-bearing potential (ie, women who are premenopausal or not surgically sterile):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Ki Min, MD | Seoul St. Mary's Hospital | Principal Investigator |
| Sung-Soo Yoon, MD | Seoul National University Hospital | Principal Investigator |
| Jin Seok Kim, MD | Severance Hospital | Principal Investigator |
| Elisabet Manasanch, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Seoul National University Hospital |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Phase 1b: CWP232291, Lenalidomide, Dexamethasone |
| Drug |
CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy. |
|
Area under the plasma concentration versus time curve (AUC) of 'CWP232291'
| Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion |
| Cmax as a pharmacokinetic parameter of metabolites of ' CWP232204' | Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291' | Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion |
| AUC as a pharmacokinetic parameter of metabolites of ' CWP232204' | Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291' | Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion |
| Seoul |
| South Korea |
| Seoul St.Mary's Hospital | Seoul | South Korea |
| Yonsei Severance Hospital | Seoul | South Korea |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |